Effects of policosanol in the functional recovery of non-cardioembolic ischemic stroke hypertensive patients. / Efectos del policosanol en la recuperacion funcional de pacientes hipertensos con ictus isquemico no cardioembolico.

INTRODUCTION: Clinical studies results show that policosanol (20 mg/day) + aspirin therapy had benefits versus placebo + aspirin to patients with recent non-cardioembolic ischemic stroke. AIM: To analyze the policosanol treatment effects in the hypertensive patients included in two non-cardioembolic ischemic stroke recovery trials. PATIENTS AND METHODS: Hypertensive patients with a modified Rankin Scale (mRS) score 2 to 4 were randomized, within 30 days of onset, to policosanol + aspirin or placebo + aspirin, for six months. The primary outcome was mRS score reduction. RESULTS: One hundred forty two hypertensive patients (mean age: 66 years) were included in the analysis. Policosanol + aspirin decreased significantly the mRS score mean from the first interim check-up. The policosanol treatment effect did not wear off, on the contrary, even improved after six months therapy. More over, policosanol + aspirin (80.3%) treatment achieved significant results (mRS <= 1), whereas the placebo + aspirin did not (8.5%). Two patients discontinued and four (two from each group) referred mild adverse events. CONCLUSIONS: The treatment for six months with policosanol + aspirin in hypertensive patients who had suffered a non-cardioembolic ischemic stroke proved to be more effective than the placebo + aspirin treatment in the functional recovery of these patients.

TITLE: Efectos del policosanol en la recuperacion funcional de pacientes hipertensos con ictus isquemico no cardioembolico.Introduccion. Los resultados de los estudios clinicos muestran que el tratamiento con policosanol (20 mg/dia) + aspirina produce beneficios frente a placebo + aspirina en pacientes con ictus isquemico no cardioembolico reciente. Objetivo. Analizar los efectos del tratamiento con policosanol en pacientes hipertensos incluidos en dos ensayos de recuperacion de ictus isquemico no cardioembolico. Pacientes y metodos. Pacientes hipertensos que sufrieron un ictus en los 30 dias previos y que, con una puntuacion de 2 a 4 en la escala de Rankin modificada (mRS), se distribuyeron aleatoriamente en dos grupos y recibieron policosanol + aspirina o placebo + aspirina durante seis meses. La variable primaria de eficacia fue la reduccion de la puntuacion en la mRS. Resultados. Se incluyo a un total de 142 pacientes hipertensos (edad media: 66 años) en el analisis. El policosanol + aspirina disminuyo significativamente la puntuacion de la mRS desde el primer chequeo intermedio. El efecto del tratamiento con policosanol no desaparecio, sino que incluso mejoro despues de seis meses de tratamiento. El numero de pacientes que alcanzaron valores de la mRS <= 1 fue mayor en el grupo de policosanol + aspirina (80,3%) que en el de placebo + aspirina (8,5%). Dos pacientes causaron baja del estudio y cuatro (dos de cada grupo) refirieron efectos adversos leves. Conclusiones. El tratamiento durante seis meses con policosanol + aspirina a pacientes hipertensos que habian sufrido un ictus isquemico no cardioembolico demostro ser mas efectivo que el tratamiento con placebo + aspirina en su recuperacion funcional.

A long-term study of policosanol in the treatment of intermittent claudication.

Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. This study was undertaken to investigate the long-term effects of policosanol administered to patients with moderately severe intermittent claudication. The study consisted of a 6-week single-blind, placebo-controlled run in phase, followed by a 2-year double-blind, randomized treatment step. Fifty-six patients who met study entry criteria were randomized to receive placebo or policosanol 10 mg twice daily. Walking distances on a treadmill (constant speed 3.2 km/h, slope 10 degrees, temperature 25 degrees C) were assessed before and after 6, 12, 18, and 24 months of treatment. Both groups were similar at randomization. After 6 months of therapy, policosanol significantly increased (p < 0.01) the initial claudication distance from 125.9 +/- 8.7 m to 201.1 +/- 24.8 m and the absolute claudication distance from 219.5 +/- 14.1 m to 380.7 +/- 50.2 m. Both variables remained unchanged in the placebo group (p < 0.01). These effects did not wear off but improved after long-term therapy, so that final values were 333.5 +/- 28.6 m (initial claudication distance) and 648.9 +/- 54.1 m (absolute claudication distance); both significantly greater (p < 0.0001) than those obtained in the placebo group, which showed values of 137.9 +/- 21.8 m (initial claudication distance) and 237.7 +/- 28.1 m (absolute claudication distance), respectively. At study completion, 21 policosanol and 5 placebo patients attained increases in claudication distance values > 50% (p < 0.001). Policosanol, but not placebo, significantly increased the ankle/arm pressure index. In addition, from month 6 up to study completion, the frequency of patients reporting improvement of lower limb symptoms was greater in the policosanol group than in the placebo group. The treatment was tolerated well. There were 16 withdrawals (12 placebo, 4 policosanol) from the study. Eight patients in the placebo group experienced a total of 10 serious adverse events, 8 of which were vascular events, compared with none in the policosanol group (p < 0.01). In addition, 3 patients in the policosanol group and 3 patients in the placebo group reported mild adverse events during the study. The present results demonstrate the long-term usefulness of policosanol therapy to treat patients with intermittent claudication.

Effect of policosanol on arterial blood pressure in rats. Study of the pharmacological interaction with nifedipine and propranolol.

BACKGROUND: Policosanol is a natural mixture of higher aliphatic primary alcohols isolated from sugar cane wax (Saccharum officinarum, L) with cholesterol-lowering effects demonstrated in experimental models and in patients with type II hyperlipoproteinemia. The purpose of this study is to determine the effect of policosanol on arterial blood pressure and its interaction with propranolol and nifedipine. METHODS: Single doses of policosanol (25, 50 and 200 mg/kg) orally administered to spontaneously hypertensive rats (SHR) did not significantly change arterial pressure. RESULTS: The study on pharmacological interactions between policosanol (200 mg/kg) and both antihypertensive agents revealed that pretreatment with high doses of policosanol significantly increased propranolol-induced hypotensive effects, while the effects of nifedipine remained unchanged. CONCLUSIONS: Our results show that policosanol does not antagonize the hypotensive effect of beta-blockers but it can increase the hypotensive effect of beta-blockers without modifying cardiac frequency.

Treatment of hypercholesterolemia in NIDDM with policosanol.

OBJECTIVE: To determine whether elevated levels of cholesterol and low-density lipoprotein (LDL) cholesterol in non-insulin-dependent diabetes mellitus (NIDDM) patients could be decreased by policosanol, a new cholesterol-lowering drug. NIDDM predisposes patients to coronary artery disease (CAD) through the direct action of hyperglycemia on the arteries as well as the dyslipidemia induced by NIDDM. RESEARCH DESIGN AND METHODS: This double-blind placebo-controlled trial was performed in 29 patients with NIDDM and hypercholesterolemia. After stable glycemic control was achieved by diet and/or oral hypoglycemic drugs, patients were instructed to follow a cholesterol-lowering diet for 6 weeks. Patients who met entry criteria received, under double-blind conditions, policosanol (5 mg) or placebo tablets twice a day for 12 weeks. RESULTS: Policosanol (10 mg/day) significantly reduced total cholesterol by 17.5% and LDL cholesterol by 21.8% compared with baseline and placebo. Furthermore, high-density lipoprotein (HDL) cholesterol was raised by 11.3% (not significant), and triglycerides showed a statistically nonsignificant decrease of 6.6%. These changes in lipid profile were similar to those induced by policosanol in nondiabetic patients with type II hyperlipoproteinemia. CONCLUSIONS: Glycemic control was unaffected by treatment. No clinically or biochemically adverse effects attributable to treatment were observed. Only one patient (placebo) withdrew from the trial because of an adverse experience (erythema). We concluded that policosanol is effective and safe in patients with NIDDM and hypercholesterolemia.

Carcinogenicity of policosanol in Sprague Dawley rats: a 24 month study.

The effects of policosanol (50-500 mg/kg) administered orally for 24 months to Sprague Dawley rats of both sexes were investigated. No differences related to daily clinical observations, weight gain, food consumption, or mortality (survival analysis) between groups were found. Histopathological study showed that the frequency of the occurrence of non-neoplastic and neoplastic (benign and malignant) lesions was similar in the control and policosanol-treated groups. The lesions observed in this study were similar to the spontaneous lesions reported in this species in previous studies. Since no drug-related increase in the occurrence of malignant or benign neoplasms was found, nor acceleration in tumors growth in any specific group was observed, this study shows no evidence of policosanol induced carcinogenicity in this strain of rats.